The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0746-2023·Announced 2023-05-31

Heparin Solution Recalled Due to Sterility Assurance Failure

Central Admixture Pharmacy Services is recalling 2,992 bags of heparin solution nationwide due to failure of sterility assurance discovered during FDA inspection.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with a risk-of-harm product (injectable sterile solution) where potential contamination from sterility failure could cause serious infection. No illnesses or injuries have been reported.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 2,992 bags of heparin added to 0.9% sodium chloride injection (2,500 units/500 mL per bag) distributed nationwide. The affected lot numbers are: 37-888833 (expires 05/02/2023), 37-890537 (expires 05/09/2023), 37-892161 and 37-892163 (expire 05/16/2023), 37-893979 and 37-893992 (expire 05/23/2023), and 37-895755 and 37-895758 (expire 05/30/2023).

The manufacturer initiated the recall after an FDA inspection raised questions about whether these sterile products maintained their sterility. Lack of assurance of sterility in an injectable medication represents a significant quality and safety concern, as contamination could potentially cause serious infection.

The recalled product

Product
heparin added to 0.9% sodium chloride, 2,500 units/500 mL* (5 units/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8100-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Sterile Injectable
Hazard
Affected units
2,992

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • Lot # 37-888833
  • Exp 05/02/2023
  • 37-890537
  • Exp 05/09/2023
  • 37-892161
  • 37-892163
  • Exp 05/16/2023
  • 37-893979
  • 37-893992
  • Exp 05/23/2023
  • 37-895755
  • 37-895758
  • Exp 05/30/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 108 recalled by Central Admixture Pharmacy Services, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 108 products in this recall →

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